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Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00526318
Recruitment Status : Unknown
Verified July 2015 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 10, 2007
Last Update Posted : July 16, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.

PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.


Condition or disease Intervention/treatment
Neuroblastoma Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vindesine Procedure: autologous hematopoietic stem cell transplantation Radiation: iobenguane I 131 Radiation: radiation therapy

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)
Study Start Date : January 2007
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Event-free survival (EFS)

Secondary Outcome Measures :
  1. Overall survival (OS)
  2. Impact of well established clinical and molecular risk factors on EFS and OS
  3. Early response, measured after 2 courses of induction chemotherapy
  4. Response to induction therapy, measured before autologous stem cell transplantation
  5. Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy
  6. Impact of the extent of initial and best surgery on outcome and frequency of complications
  7. Acute and late toxicity of radiotherapy
  8. Correlation of MIBG activity with whole-body radiation dose
  9. Molecular markers (MYCN and status of chromosome 1p and 11q)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma according to any of the following criteria:

    • Histological diagnosis from tumor tissue
    • Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
  • High-risk disease, meeting 1 of the following criteria:

    • Stage 4 disease, regardless of the MYCN status (1-21 years of age)
    • Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age)

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception (hormonal contraception or intra-uterine device [IUD])

PRIOR CONCURRENT THERAPY:

  • No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial
  • No other concurrent anticancer therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526318


  Show 68 Study Locations
Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
Study Chair: Frank Berthold, MD Children's Hospital Medical Center, Cincinnati
More Information

ClinicalTrials.gov Identifier: NCT00526318     History of Changes
Other Study ID Numbers: GPOH-NB2004-HR
CDR0000564820 ( Registry Identifier: PDQ (Physician Data Query) )
UNI-KOELN-161
EU-20661
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
disseminated neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Melphalan
Ifosfamide
Liposomal doxorubicin
Etoposide phosphate
Carboplatin
Doxorubicin
Etoposide
Vincristine
Topotecan
3-Iodobenzylguanidine
Vindesine
Isotretinoin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action